A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy

Completed

• Conditions: Hemostasis

• Registration Number: NCT03896061
• Lead Sponsor: Ethicon, Inc.

Brief Summary

Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.

Detailed Description

Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.

Data collected for the study consists of videography imaging and audio. Video recordings (no subject identifiers) will involve the use of two cameras providing:

1. Synchronized Internal and external views of devices used, including the hands of the surgeon firing the endocutter; and

2. Audio of the procedure to record the motor noise of the device while firing (audio will help identify the surgeon's pulsing technique during the procedure).

Surgeon satisfaction with transection technique will also be collected. Videography will be evaluated for staple line hemostasis and need for surgical intervention at the staple line (defined in Criteria for Evaluation).

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-03-29
• Study Start: 2019-04-15
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Willingness to sign a Video, Audio and Digital Data Release consent for participation; and
• Scheduled for a laparoscopic sleeve gastrectomy procedure.

Exclusion Criteria

• Prophylactic use of buttressing material
• Other staple line reinforcement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of oozing/bleeding at the staple line	Intraoperative	Investigate whether use of a prescribed pulsing technique may provide potential reduction in the occurrence of oozing/bleeding at the staple line.
Occurence of sugical interventions required to achieve hemostasis at the staple line	Intraoperative	Investigate whether use of a prescribed pulsing technique may provide potential reduction in the occurrence of surgical interventions required to achieve hemostasis at the staple line.

Trial Locations

Locations (3)

Surgical Specialists of Louisiana; 🇺🇸 Metairie, Louisiana, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

State University of New York at Buffalo; 🇺🇸 Buffalo, New York, United States